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Senior Clinical Research Associate (CRA) – Maryland Remote Contract
Contract Senior Clinical Research Associate overseeing clinical trial sites for Lotus Clinical Research. The role covers GCP compliance, essential documentation, investigational product accountability, and study close-out.
विवरण
- Independently oversee and monitor site activities across assigned clinical studies
- Conduct site qualification, initiation, interim monitoring, and close-out visits
- Maintain compliance with study protocols, Lotus or Sponsor SOPs, FDA regulations, and ICH-GCP requirements
- Evaluate clinical sites and assess investigator and site capabilities
- Lead study initiation tasks, review protocols and regulatory matters, and train site personnel
- Keep Investigator Site Files audit-ready and upload required documents to the Trial Master File
- Coordinate with investigational sites on visit scheduling, query resolution, action items, and site management
- Track clinical trial material accountability, stability, and storage conditions, and complete investigational product inventories
- Manage site correspondence and support timely clinical data transmission
- Complete close-out visits, investigational product reconciliation and disposition, study file reconciliation, database-lock query resolution, and remaining action items
- Finish internal and study-specific training within required deadlines
- Handle pre- and post-visit follow-up, including confirmation letters, follow-up correspondence, and monitoring reports
- Partner with the CRA Line Manager on CRA and junior staff mentoring, training, and assessment when applicable
आवश्यकताएँ
- Bachelor’s degree or equivalent experience in life sciences or healthcare
- At least five years of field experience as a Clinical Research Associate
- Demonstrated mastery of CRA II responsibilities
- Valid driver’s license
- Legal authorization to work in the United States as an independent contractor through an LLC, INC., or agency
- Ability and willingness to travel up to 100% domestically by land and air
- Expertise in drug development, ICH guidelines, GCP, and clinical trial operations
- Proficiency with electronic case report form platforms and related processes
- Strong interpersonal, organizational, and multitasking abilities
- Exceptional attention to detail and professional judgment
- Ability to uphold ICH GCP requirements and select appropriate responses to complex issues
- Capacity to manage multiple deadlines while working independently
- Proficiency with computers, email, document, spreadsheet, and presentation software
- Ability to submit invoices and expense reports on time in accordance with Finance Department requirements
- Ability to meet physical requirements, including occasional lifting or carrying of up to 10 pounds
- Willingness to follow safety, environmental, infection-control, and protective-equipment requirements while traveling to or visiting clinical research sites
लाभ
- The contractor is responsible for obtaining and maintaining personal insurance
- Option to work from a home office
- Opportunity to mentor, train, and assess CRAs and junior staff
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